Court Rules Against Sanofi In Lovenox Patent Case Again; Second Round Of Appeals Likely
This article was originally published in The Pink Sheet Daily
Executive Summary
Denial of a second appeal of a U.S. District Court’s decision that Teva and Amphastar are not infringing the Lovenox patent could open door to generic launches.
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A federal court has ruled against Sanofi-Aventis in its Lovenox patent infringement suit against Teva and Amphastar for the second time, likely setting up another round of appeals. Sanofi announced Feb. 9 that the U.S. District Court for the Central District of California ruled that its patent no. 5,389,618 for enoxaparin is invalid. The company said it is "evaluating its options for further legal recourse and will continue to vigorously defend its intellectual property rights." Stakeholders following the case say that if Sanofi fails in its second appeal, two Lovenox patents would be automatically invalidated, opening the door to generic competition for the injectable antithrombotic. The District Court previously ruled in favor of Amphastar and Teva in 2005, concluding the patent was invalid due to inequitable conduct (1 (Also see "Lovenox Patent Invalidity Ruling Could Open Door To Near-Term Generics" - Pink Sheet, 16 Jun, 2005.)). However, the U.S. Court of Appeals sent the case back to the lower court on Sanofi's appeal (2 (Also see "Sanofi Lovenox Patent To Return To Court" - Pink Sheet, 10 Apr, 2006.)). Sanofi also is involved in patent infringement litigation in New Jersey federal court with Sandoz and Cambridge, Mass.-based Momenta (3 (Also see "Lovenox’ Days In Court" - Pink Sheet, 10 Aug, 2006.)). Momenta CEO Craig Wheeler told "The Pink Sheet" DAILY he believes Sanofi will appeal the latest decision. Wheeler said he is "very pleased" with the outcome in California, adding that if Sanofi's second appeal is denied, both the '618 patent and reissue patent no. 38743, which is the subject of Sanofi's case against Momenta, would be automatically invalidated. The '618 and RE '743 patents are set to expire in February 2012, according to FDA's "Orange Book." Rancho Cucamonga, Calif.-based Amphastar and Israel-based Teva were the first to file ANDAs with a Paragraph IV certification to the '618 patent in 2003. Momenta and Sandoz entered into an agreement to develop generic enoxaparin the same year and filed an ANDA in August 2005. According to Wheeler, Momenta's application is at the 18-month mark in its FDA review; tentative approval could occur by September. Since Amphastar and Teva were first to file a Paragraph IV challenge and would have 180-day marketing exclusivity, Momenta's launch plans for enopaxarin would depend on that timeline, if those applications are cleared. -Brooke McManus ([email protected]) |